title: Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.
abstract: OBJECTIVE
  Hot flashes occur in approximately 80% of androgen-deprived men. Few intervention studies have been conducted to relieve hot flashes in men.
  
  
  METHODS
  Eligible androgen-deprived men were randomly assigned to one of four daily regimens (2 × 2 factorial design) for 12 weeks: milk protein powder and placebo pill, venlafaxine and milk protein powder, soy protein powder and placebo pill, or venlafaxine and soy protein powder. The primary end point was hot flash symptom severity score (HFSSS), defined as number of hot flashes times severity. The secondary end point was quality of life (QoL), assessed by using the Functional Assessment of Cancer Therapy-Prostate.
  
  
  RESULTS
  In all, 120 men age 46 to 91 years participated. Most were white (78%) and overweight or obese (83%). Toxicity was minimal. Neither venlafaxine nor soy protein alone or in combination had a significant effect on HFSSS. Soy protein, but not venlafaxine, improved measures of QoL.
  
  
  CONCLUSIONS
  In androgen-deprived men, neither venlafaxine nor soy proved effective in reducing hot flashes. Interventions that appear effective for decreasing hot flashes in women may not always turn out to be effective in men.
authors.affiliation: Mara Z. Vitolins, Leah Griffin, Bart Frizzel, Glenn J. Lesser, Michelle Naughton, and Edward G. Shaw, Wake Forest School of Medicine; Dawn Moose, Novant Health, Winston-Salem; James E. Radford Jr, Hendersonville Hematology/Oncology, Hendersonville, NC; W. Vic Tomlinson, AnMed Health, Anderson, SC; Jacqueline Vuky, Virginia Mason Medical Center, Seattle, WA; and Paul T. Adams, National Surgical Adjuvant Breast and Bowel Project, Genesys Regional Medical Center, Flint, MI.
authors.forename: Mara Z
authors.initials: MZ
authors.lastname: Vitolins
authors.forename: Leah
authors.initials: L
authors.lastname: Griffin
authors.forename: W Vic
authors.initials: WV
authors.lastname: Tomlinson
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Vuky
authors.forename: Paul T
authors.initials: PT
authors.lastname: Adams
authors.forename: Dawn
authors.initials: D
authors.lastname: Moose
authors.forename: Bart
authors.initials: B
authors.lastname: Frizzell
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Lesser
authors.forename: Michelle
authors.initials: M
authors.lastname: Naughton
authors.forename: James E
authors.initials: JE
authors.lastname: Radford
authors.forename: Edward G
authors.initials: EG
authors.lastname: Shaw
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000009:adverse effects*; D003511:Cyclohexanols / Q000627:therapeutic use*; D004311:Double-Blind Method; D019584:Hot Flashes / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D030262:Soybean Proteins / Q000627:therapeutic use*; D000069470:Venlafaxine Hydrochloride
chemical_list: D000726:Androgen Antagonists; D003511:Cyclohexanols; D017367:Selective Serotonin Reuptake Inhibitors; D030262:Soybean Proteins; D000069470:Venlafaxine Hydrochloride